Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment grt (guided relaxation training)
Phase phase 0
Sponsor Trinitas Comprehensive Cancer Center
Collaborator Aptium Oncology Research Network
Start date July 2009
End date July 2013
Trial size 40 participants
Trial identifier NCT00945607, 09-IM-01

Summary

The primary objectives of this study are to determine if the use of Guided Relaxation Training (GRT) during cancer treatment in individuals with newly diagnosed breast cancer increases their ability to cope as measured by the Coping Self-Efficacy Scale (CSES) and reduces their perceived stress as measured by the Perceived Stress Scale (PSS).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose supportive care
Arm
(Experimental)
Eligible subjects who have been randomized to the intervention arm will be scheduled for GRT introduction and training with a research staff member. The GRT sessions will consist of six weekly on-site sessions in which the subject is provided instructions and then allowed to listen to the GRT CD. Subjects will be instructed to conduct independent GRT sessions at home, twice daily, at least four hours apart, for the duration of the study. Subjects will also be instructed that on the days of one-on-one sessions with a research staff member at TCCC, that they will only be required to perform the independent session once at home. Subjects will be provided with a diary to record the date and time of each independent GRT session performed at home. Subjects will be instructed to bring their completed diary with them at each subsequent visit.
grt (guided relaxation training)
Weekly on-site GRT sessions at the center in combination with twice daily independent GRT sessions at home.
(No Intervention)
Eligible subjects who are randomized to the SOC arm will not receive the GRT sessions. During the six week treatment phase, these subjects will only receive SOC provided to all subjects newly diagnosed with breast cancer at TCCC. This consists of an education session with the nurse or nurse practitioner. In addition, they will also be provided with supportive care and symptom management as needed. This arm will also be provided with a diary to record their stress level at least twice daily.

Primary Outcomes

Measure
Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer reduces their perceived stress.
time frame: Endpoint
Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer increases their coping ability.
time frame: Endpoint

Secondary Outcomes

Measure
Determining the effects of GRT on vital signs and self-reported levels of fatigue.
time frame: End Point
Determining differences of perceived levels of stress among various racial and ethnic groups.
time frame: End Point

Eligibility Criteria

Female participants from 18 years up to 75 years old.

Inclusion Criteria: - Able to speak and understand English - At or between the ages of 18 and 75 - Newly diagnosed with breast cancer (within 12 weeks of study entry) - Expected to receive chemotherapy and/or radiation - Willingness to complete CSES, PSS-14 and FACIT-F scales - Minimum score of 4 on the 0-10 Visual Analog Scale for stress - Willingness to participate for the 18 week duration of study and follow-up - Ability to travel to cancer center weekly specifically for on-site guided relaxation training sessions - Access to a CD player Exclusion Criteria: - Cognitive or mental status affecting ability to follow directions - Previous or current use of complementary therapies for their cancer diagnosis, except herbal supplements - Brain metastasis - Treatment for any other diagnosis of cancer within the previous 5 years - Any condition that, in the opinion of the investigator might interfere with the subject's participation in the study, pose an added risk for the subject or confound the assessment of the subject

Additional Information

Official title Guided Relaxation Training for the Reduction of Self-Reported Stress in Individuals With Newly Diagnosed Breast Cancer
Principal investigator Carol S Blecher, RN, MS, AOCN, APNC
Description This is a study of self-reported stress in individuals with newly diagnosed breast cancer. Subjects will be randomized to either the standard of care (SOC) arm or the intervention arm. The principle investigators will be blinded to the arm assignment. The intervention utilized will be six weekly on-site GRT sessions. In addition, subjects will be provided with a CD utilizing a standardized GRT script and music for home use twice daily during the study period. During the intervention period, they will also be provided with a diary and required to keep a record of date and time of CD utilization at home. The subjects will also be required to record their stress level before and after each of the two home sessions. The sessions must be at least 4 hours apart. The SOC arm will consist of an education session with the nurse or nurse practitioner and supportive care / symptom management as needed. This group will also be required to keep a daily diary in which they record their stress levels twice daily, at intervals separated by at least 4 hours.
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Trinitas Comprehensive Cancer Center.